Years of Experience: 5.5 to 7 years
Skill Set / Exposure: Quality Background, CSV, UAT Testing, Data Integrity, Stakeholder management, GXP, Application Lifecycle Management and (SAS/Linux/Python) Preferred.
Location: Bangalore
Job Purpose:
- This is an advanced-level analyst role within ISS for candidates with <8 years’ relevant experience.
- This role works in a matrix environment partnership with one or more cross-functional business groups to develop, standardize, improve & maintain business, technical & system functionality & processes to achieve the expected business benefits.
- Develop proficiency to serve as point of contact for questions related to assigned functional area(s) & Low-high risk systems for internal & external customers, as appropriate.
- Expected to develop skills as an internal expert in an assigned area or areas.
- Apply knowledge and experience in execution of job responsibilities.
Key Responsibilities:
- Support, and act as, business system owner for clinical development systems and ensure that system is fit for purpose.
- Build working relationship with internal business, IT groups, cross functional expert user groups and external vendors.
- Ensure helpdesk support for system-related issues/queries. Act as business escalation point in terms of major system issues and ensure that root cause analysis of major incidents is undertaken.
- Consistently coordinate and execute QMS procedures and system SOPs.
- Create, review, and approve system and validation documents (Validation Plan & Report, Risk Assessments, Requirement Specifications etc.).
- Ensure user documentation and process documents exist for system (Work Instructions, User Guide, User Training, Newsletters, Communications etc.).
- Ensure that the system is kept audit-ready and is maintained in compliance with all legislative and regulatory requirements.
- Represent system in the event of an audit (internal or external), provide formal responses and ensure implementation of any corrective actions.
- Ensure data integrity is maintained and that all data integrity-related principals and policies are consistently applied and maintained.
- Oversee and engage users, stakeholders, and other interfacing functional areas in the defining user requirements and in user acceptance testing; ensuring that functionality and performance align to business need. Create, Review, and execute test cases.
- Oversee release management including change control tracking and verification. Develop knowledge of technical components of system and ability to apply that knowledge to the business need.
- Establish system governance for agreement & prioritization of goals, strategic planning, and oversight of risk management.
- Ensure appropriate integration with other systems.
- Involve with all business-related areas of the system development lifecycle for a system, including archival and decommissioning activities at the end of a system’s life.
Education Requirements:
- Master’s/ Bachelor’s degree in Engineering/Technology.
- Master’s/ Bachelor’s degree in Pharmacy.
- Master of Computer Application (MCA).
- MSc in Computer Science/Information Technology.
Job Related Experience:
- Experience in Validation of Computerized Systems in a regulated environment within Biopharma industry, including familiarity with Documentations and Testing.
- High level understating of business process, systems and technology supporting Clinical Trial Development.
- Ability to collaborate with stakeholders to accomplish individual and organizational objectives.
- Experience in Quality systems and Quality Management, including process definition and process improvement, within an Information Systems Environment.
- Experience in representing the systems in Audit and Regulatory inspections.
- Experience in the management of system and validation documentations, ensuring compliance with applicable industry regulations and, Company Policies and Standards.
Other Job-Related Skills:
- ITIL Foundation.
- Six Sigma Green Belt.
- ISO Lead Auditor.
Inclusion & Diversity at GSK:
- At GSK, we are dedicated to fostering an inclusive and diverse work environment. We believe that diversity in our workforce drives innovation and growth, and we are committed to providing equal opportunities for all employees and applicants. We strive to create an atmosphere where all individual’s unique perspectives and experiences are valued and respected. All qualified applicants will receive equal consideration for employment without regard to their sex or gender, caste, pregnancy, gender identity/expression, physical and/or mental disability, or any other protected characteristic as per applicable law.“
Why GSK?
Uniting science, technology and talent to get ahead of disease together.
GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).
Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.
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